Occupational Health and Safety and Infection Prevention & Control guidance, and facility guidance: http://www.health.gov.on.ca/en/pro/programs/publichealth/coronavirus/2019_guidance.aspx
Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment; Therefore, the Minister of Health, pursuant to subsection 30.1(1) of the Food and Drugs Act, makes the annexed Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. Ottawa, March 18, 2020 Patty Hajdu Minister of Health
Partnership with the WHO produced 1-hour webinars: https://ced.ifmbe.org/blog/who-ced-covid19-townhalls.html
https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73137a-eng.php
UV Disinfection: https://assets.ecri.org/PDF/COVID-19-Resource-Center/COVID-19-Clinical-Care/COVID-Alert-UV-Disinfection.pdf
More detailed discussion of this guidance can be found in a webinar here: https://www.ecri.org/landing-covid-19-medical-devices-respirator-masks Broadly, ECRI recommends that one follow guidelines (in the US, these are CDC and NIOSH guidelines, the latter of which are being used to certify masks in Ontario): https://www.cdc.gov/niosh/topics/hcwcontrols/recommendedguidanceextuse.html
- Minimize amount of personnel needing to use respiratory protection (engineering and administrative controls)
- Use alternatives to N95 respirators (e.g., other classes of filtering facepiece respirators, elastomeric half-mask and full facepiece air purifying respirators, powered air purifying respirators)
- Allow extended use or limited reuse of respirators (e.g. reuse for pathogens in which contact transmission is not a concern)
- Clarify doffing and donning protocols for equipment to solely be in use when in contact with patients
- Prioritize the use of N95 respirators for those personnel at the highest risk of contracting or experiencing complications of infection
Safety of Extended Use: https://assets.ecri.org/PDF/COVID-19-Resource-Center/COVID-19-Clinical-Care/COVID-ECRI-N95-Respirators.pdf
ECRI supports prioritizing extended use over reuse because:
- The reported pathogen transfer risk from N95s is high by contact (donning and doffing) but low by aerosol (spread by breathing through a used mask).
- Use of surgical masks or similar disposable covers over N95s during extended use are unlikely to result in significant adverse effects.
- Mechanical failure (e.g., broken straps and poor sealing between the mask and the user’s face) with only a few reuses was common across FDA-cleared (i.e., for medical use) N95s.
ECRI has developed a summary report summarizing the “Disinfection of N95 Respirators: UV Light May Be Considered For Limited Reuse Situations” [ECRI Exclusive User Experience Network] (Health Devices Alerts 2020 Apr 3. Accession No. S0394): https://www.ecri.org/EmailResources/Health%20Devices/ECRI_COVID-19_Alert_S0394.pdf In this summary, third party testing suggests that radiation levels from 1800 mJ/cm^2 or 120,000 mJ/cm^2 are insufficient to degrade filtration and air flow resistance for respirators past NIOSH requirements. Testing was conducted on four respirator brands: 3M 1860, 3M 9210, Gerson 1730, Kimberly-Clark 46727. More details can be found here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4699414/
ECRI suggests:
- 5 use minimum (or less if recommended by manufacturer)
- 18.4 mJ/cm^2 to 59 mJ/cm^2 at 254 nm (expecting a 3-log reduction of viral particles)
AAMI hosted a webinar on the decontamination process, and concluded that best practices consist of evaluating the evidence. They also suggested beyond UV decontamination that vaporized hydrogen peroxide may be an effective solution. A National Institute of Standards and Technology tool was developed to facilitate this process: https://www.nist.gov/services-resources/software/tool-evaluation-vaporized-hydrogen-peroxide-disinfection-n95-masks-small This spreadsheet tool estimates the vaporized hydrogen peroxide (VHP) concentration in air of rooms used for VHP mask disinfection systems. The tool employs a single-zone mass balance analysis that accounts for room size, VHP losses to surfaces and air change rate. This tool is intended to support VHP disinfection efforts by providing estimates of VHP concentrations in the room being employed, but it does not describe or provide guidance on VHP disinfection applications.
The University of Nebraska Medical Center has developed a protocol now being referenced by multiple sources: https://www.nebraskamed.com/sites/default/files/documents/covid-19/n-95-decon-process.pdf. This protocol is for surface decontamination and reuse of N95 respirators building upon CDC recommendations https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html which suggest that: Disposable filtering facepiece respirators (FFRs) are not approved for routine decontamination and reuse as standard of care. However, FFR decontamination and reuse may need to be considered as a crisis capacity strategy to ensure continued availability. Based on the limited research available, ultraviolet germicidal irradiation, vaporous hydrogen peroxide, and moist heat showed the most promise as potential methods to decontaminate FFRs.
Contracting work by a third party (Applied Research Associates) produced guidance regarding the engineering particulars of reuse: https://www.ara.com/news/ara-research-mitigate-shortage-respiratory-protection-devices-during-public-health-emergencies
The FDA has updated its emergency use authorization regarding ventilator decontamination, to address concern regarding “authorized respirators manufactured in China [which] may vary in their design and performance”: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reissues-emergency-use-authorizations-revising-which-types
Today, the U.S. Food and Drug Administration (FDA) issued an updated Letter to Health Care Personnel and Facilities: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators. The FDA is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems (revocation effective June 30, 2021). As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. These actions are in follow-up to the May 27, 2021, letter in which the FDA recommended a transition away from non-NIOSH-approved disposable respirators as well as from reusing decontaminated or bioburden-reduced disposable respirators. https://www.fda.gov/medical-devices/letters-health-care-providers/update-fda-no-longer-authorizes-use-non-niosh-approved-or-decontaminated-disposable-respirators
As of 4/4/20 Public Health Ontario has synthesized literature on the topic which supports the guidance provided above: https://www.publichealthontario.ca/-/media/documents/ncov/covid-wwksf/what-we-know-reuse-of-personal-protective-equipment.pdf?la=en There is no clear scientific consensus regarding the use or reuse of equipment and PHO defers to American sources (primarily NIOSH and CDC). UV radiation is the most suggested potential form of decontamination, and the Nebraska protocol of UVGI at 300 mJ/cm^2. Two 254nm UV lamps are directed towards wire hanging masks in a UV chamber for approximately 5 minutes per cycle. This is a modification from the earlier 60 mJ/cm^2 suggested in reference of the Nebraska Medicine report, as the report changed its recommendations.
Lab tour on alternative ventilator selection https://www.ecri.org/landing-covid-19-ventilator-shortages, selection sequence:
Ventilator sharing guidance from the Society of Critical Care Medicine (SCCM), American Association for Respiratory Care (AARC), American Society of Anesthesiologists (ASA), Anesthesia Patient Safety Foundation (APSF), American Association of Critical‐Care Nurses (AACN), American College of Chest Physicians (CHEST): https://www.aarc.org/joint-statement-guidance-document-on-multiple-patients-per-ventilator/
The above‐named organizations advise clinicians that sharing mechanical ventilators should not be attempted because it cannot be done safely with current equipment. Attempting to ventilate multiple patients with COVID‐19, given the issues described here, could lead to poor outcomes and high mortality rates for all patients cohorted. It is better to purpose the ventilator to the patient most likely to benefit than fail to prevent, or even cause, the demise of multiple patients.
Benchmarks for anesthesia units and vaporizers to certify operation:
Although the FDA has not received any adverse event reports related to the use of ventilator splitters authorized for emergency use during the COVID-19 pandemic, recent literature describes risks that may be associated with using certain ventilator splitters. After considering this recent literature, the FDA is informing health care providers and health care facilities that the literature indicates that certain features are associated with better performance.
A training site has been developed for ventilators which contains manuals, guides and video material for Draeger, GE, Getinge, Hamilton Medical, Medtronic, Nihon Kohden, Philips and Vyaire: https://vta.allego.com/home.do
IFMBE Clinical Engineering Division Critical Topic Webinar: Mechanical Ventilators
ECRI lab tour: https://www.ecri.org/landing-covid-anesthesia-units-ventilators Recommended that clinical engineers begin by:
- Identifying that anesthesia machines are a top alternative to ICU ventilators
- Inventory availability off anesthesia units
- Inventory supplies (viral filters, HMEs, breathing circuits, CO2 absorbent
- Start preparing now for both machine and staffing (anesthesia machines require 24/7 monitoring) alongside respiratory therapy
A comparison of anaesthesia units and ICU ventilators for easy conversation points to clarify regarding operation:
A landing page for guidance is provided and updated: https://www.asahq.org/in-the-spotlight/coronavirus-covid-19-information/purposing-anesthesia-machines-for-ventilators. Within the documentation provided on the webpage it contains information for manufacturer specific settings. General facts about equipment maintenance can be found here: https://www.asahq.org/about-asa/governance-and-committees/asa-committees/committee-on-occupational-health/coronavirus/clinical-faqs This is linked to and endorsed by the Canadian Anesthesiologists’ Society.
Specific guidance can be found here as of 16-Apr-2020 https://www.asahq.org/-/media/files/spotlight/anesthesia-machines-as-icu-ventilators416.pdf including specific machine settings and resources. Each manufacturer has provided resources to manage their machines:
- GE: https://www.gehealthcare.com/products/Anesthesia-Delivery-Systems-User-Resources
- Draeger: https://www.draeger.com/en-us_us/Home/novel-coronavirus-outbreak#anesthesia
- Mindray: https://www.mindraynorthamerica.com/covid-19-response/
- Getinge: https://www.getinge.com/dam/hospital/documents/marketing-sales/customer-letters/english/mcv00103387_reva_covid-19_customer_letter_long_term_ventilation_with_flow-en-us.pdf
A webinar covering the Canadian perspective is on YouTube. The society endorses British and American resources. A site describing the results of a survey to anesthesiologists across the country also highlights equipment shortages (both PPE and drugs): https://www.cas.ca/en/practice-resources/covid-19/cas-and-chiefs-covid-19-surveys#
Webinar on the topic of “Infusion Therapy - Conserving Supplies in the Age of COVID-19”: https://www.ecri.org/landing-covid-infusion-therapy Broadly, as with anesthesia drugs, there is an expected shortage predicted in the future.
Institute for Safe Medication Practices Planning for Anticipated Shortage of Smart Infusion Pumps and Dedicated Administration Sets: https://ismp.org/acute-care/special-edition-medication-safety-alert-april-9-2020/covid-19. The steps suggested to manage infusion pump shortages are:
- Identify medications requiring smart pumps.
- Take inventory of all available pumps.
- IV to oral (or IM) conversion. Organizations should switch patients from IV to oral therapies as soon as possible.
- Use IV push instead of infusions.
- Administration set change policy. Another item that should be reviewed is the hospital’s current administration set change policy.
- Potential role for gravity infusions.
- Subcutaneous infusions. Subcutaneous gravity infusions may be an option for parenteral delivery of medications and solutions for some patients.
American drug shortages can be found here: https://www.ashp.org/Drug-Shortages/Current-Shortages, and there is an expected shortage predicted in Canada. The Canadian Society of Hospital Pharmacists is currently tracking the problem, and will update their COVID-19 resource page here: https://www.cshp.ca/covid-19.
ECRI and the Association for Health Care Resource & Materials Management (AHRMM) are tracking non-traditional supplies for the domestic US and other international markets. Most of these suppliers are linked to China, and due diligence is recommended.
As of May 1st, ECRI has also compiled a product equivalents spreadsheet for various instrument components (air clearance units, breathing circuits, disinfecting wipes, HME filters, IV solutions, and universal transfer media): https://assets.ecri.org/PDF/COVID-19-Resource-Center/COVID-19-Supply-Chain/COVID-CrossCHEQ-Support-Products-05012020.xlsx as well as PPE (exam gloves, disinfecting wipes, face shields, isolation gowns, IV solutions, N95 air purifying respirators, shoe covers, surgical masks, and universal transport medium): https://assets.ecri.org/PDF/COVID-19-Resource-Center/COVID-19-Supply-Chain/COVID-CrossCHEQ_Coronavirus-PPE-05012020.xlsx. These spreadsheets are measured against key performance indicators, rather than absolute equivalence. As of June 24th, these have been updated: https://assets.ecri.org/PDF/COVID-19-Resource-Center/COVID-19-Supply-Chain/COVID-CrossCHEQ-Support-Products.xlsx
The US Centers for Disease Control held a webinar on May 7th, released on the web May 11th, discussing
“key factors to help buyers make informed procurement decisions when making a respirator purchase. The information will help to maximize the likelihood of obtaining safe and effective products that will keep workers safe.”
This webinar contains specific information about international sourcing to the United States, including information regarding the validation of products from Chinese distributors as well as ensuring they have passed NIOSH inspection (which should indicate an equivalency to evaluations in Ontario).
The US FDA has developed guidance for the 3D printing of medical devices and personal protective equipment: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/3d-printing-medical-devices-accessories-components-and-parts-during-covid-19-pandemic. This guidance suggests that such equipment requires testing and evaluation by the FDA prior to use.
Similarly, Health Canada has issued guidance: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19-unconventional-manufacturing-personal-protective-equipment.html. This guidance provides the standards for face shields and masks, as well as regulatory authorization protocols and pathways.